Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Not Applicable

• Conditions: Healthy
• Interventions: Device: ReguRate neurostimulation

• Registration Number: NCT03771794
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

Brief Summary: A randomized double-blinded, sham-controlled, crossover study

Condition or Disease: impaired autonomic balance measured by heart rate variability

Detailed Description

A randomized double-blinded, sham-controlled, crossover study

Condition or Disease: impaired autonomic balance measured by heart rate variability

Intervention/treatment:

Device: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation system

Study Design:

Study Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation: Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in healthy adults

Study Timeline

• Study Start: 2018-11-15
• Status Verified: 2018-12
• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-10
• Last Update Submitted: 2018-12-10
• Study First Posted: 2018-12-11
• Last Update Posted: 2018-12-11
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria :

1. Healthy male and female volunteers ages 25-60
2. 2 minute HRV measurement with SDNN<35 ms (below 35 ms)
3. Participants able and willing to comply with the study protocol
4. Participants able and willing to sign a written informed consent

Exclusion Criteria

Exclusion criteria :

1. Participant with a known cardiovascular disease
2. Participants with COPD
3. Participants with any known history of epilepsy
4. Participants with detected arrhythmia on test day
5. Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.)
6. Heavy smokers (more than 1 package of cigarets a day)
7. Participants with a plan to change medications
8. History of vasovagal syncope
9. Pregnancy or bleeding
10. Participants enrolled in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Comparator: ReguRate RR2 active	ReguRate neurostimulation	Device: ReguRate neurostimulation device
Sham Comparator: ReguRate RR2 sham.	ReguRate neurostimulation	Device: Sham ReguRate neurostimulation - mock sham stimulation mode

Primary Outcome Measures

Name	Time	Method
Percentage of patients with 15% or HRV change immediately after neurostimulation session	1 week	HRV augmentation

Secondary Outcome Measures

Name	Time	Method
Decrease in heart rate	1 week	Percentage of patients with 5% or more decrease in heart rate

Trial Locations

Locations (1)

Wingate Institute; 🇮🇱 Netanya, Israel